A phase 2 study, published in Annals of Internal Medicine and led by Joe Eron, MD, Director of the CFAR Clinical Core, found that a new once-weekly oral HIV treatment regimen achieved virologic suppression through 48 weeks. The study evaluated the efficacy and safety of once-weekly oral islatravir plus lenacapavir (ISL + LEN) compared to a regimen of bictegravir, emtricitabine, and tenofovir alafenamide (B/F/TAF) in virologically suppressed people with HIV (PWH) over 48 weeks. Participants were recruited from 44 sites in the U.S., including community centers, hospitals, general practices, and research centers. Inclusion criteria included being 18 years or older, receiving B/F/TAF treatment, and having an HIV-1 RNA viral load of less than 50 copies/mL for at least 24 weeks. Participants were randomly assigned to receive once-weekly ISL + LEN or to continue B/F/TAF for 48 weeks. Study visits occurred throughout the study period to assess CD4+ T-cell count, HIV RNA viral load, vital signs, and more.
The results of the study showed that participants who received the ISL+LEN regimen had high rates of virologic suppression at both 24 and 48 weeks. Changes in CD4+ T-cell and lymphocyte counts from baseline to 48 weeks were not clinically meaningful. Furthermore, no participants experienced an adverse event (AE) categorized as a grade 3 or higher. Finally, adherence rates among participants receiving the ISL+LEN regimen were 95% or higher, compared to participants receiving the daily oral B/F/TAF.
These findings suggest that a once-weekly oral HIV treatment regimen could help reduce barriers associated with adhering to a daily pill for people living with HIV. Dr. Joe Eron discussed, “People living with HIV deserve options that work not only medically, but practically. Daily pills are effective, but they’re not the right fit for everyone. Seeing such strong suppression with a once‑weekly regimen is incredibly encouraging. It suggests we may be able to offer patients a simpler approach that still delivers the control they need.”
Read more about the study and next steps here.
Read the full study here.